Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

Phase 1

Withdrawn

• Conditions: Heart Rate; Blood Pressure; Arrhythmias
• Interventions: Drug: Phenylephrine HCL; Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

• Registration Number: NCT01026961
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Study Start: 2010-09
• Primary Completion: 2010-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy volunteers between 18 and 50 years;
• Clinical examination without abnormal findings
• Ability to understand the nature and purpose of the study, including the risks and adverse effects

Exclusion Criteria

• Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia
• History of serious adverse reactions or hypersensitivity any drug
• Hypersensitivity to the drug study drugs or chemically related compounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phenylephrine hydrochloride	Phenylephrine HCL	Phenylephrine hydrochloride 10mg
Phenylephrine HCL/Acetaminophen/Dimethindene Maleate	Phenylephrine HCL/Acetaminophen/Dimethindene Maleate	Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

Primary Outcome Measures

Name	Time	Method
To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs	15 days

Secondary Outcome Measures

Name	Time	Method
To report and evaluate adverse events	15 days
Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing	15 days

Trial Locations

Locations (1)

Scentryphar Pesquisa Clinica Ltda.; 🇧🇷 Campinas, São Paulo, Brazil